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临床试验/NCT06024733
NCT06024733进行中(未招募)4 期

Effect of Total Intravenous Anesthesia by Targeted Controlled Infusion on Surgical Stress Response Compared to Inhalational Anesthesia

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年10月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
90
试验地点
1
主要终点
The level of the stress response by serum level of insulin-like growth factors

研究概览

简要总结

This study aims to compare the effect of total Intravenous anesthesia Target-controlled infusion (TIVA-TCI) with inhalational anesthesia on stress response.

详细描述

Target-controlled infusion (TCI) techniques have been used to induce and maintain general anesthesia or to provide computer-assisted personalized sedation. Target-controlled infusion (TCI) systems are computer-assisted IV infusion pumps that use pharmacokinetic and pharmacodynamic mathematical modeling to maintain a user-designated target concentration at an effect site (typically the brain).

The clinician enters a desired target concentration for an anesthetic or another agent. The computer calculates the amount of the agent required to achieve the target concentration at the effect site and directs an infusion pump to deliver the calculated boluses or infusions. Therefore, TIVA-TCI allows a more stable hemodynamic profile during surgery, prevents long-acting opioid-induced accumulation and allows rapid recovery from general anesthesia.

Total intravenous anaesthesia (TIVA) regimen with Propofol is a useful anaesthetic technique, effectively controlling responses to tracheal intubation and intense surgical stimulation, while avoiding Inhalational anaesthetics and allowing rapid emergence from anaesthesia .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients subjected to lower abdominal cancer surgery.
  • Patients of both sexes
  • body mass index < 35 kg/m
  • Age from 18 to 60 years.

排除标准

  • Patients with a history of severe cardiovascular or respiratory disease.
  • Severe hepatic, renal, or neurological diseases.

研究组 & 干预措施

inhalational

Sham Comparator

干预措施: Sevoflurane (Drug)

Target Controlled Infusion

Active Comparator

干预措施: Target Controlled Infusion (Drug)

Target Controlled Infusion and lidocaine

Active Comparator

干预措施: Target Controlled Infusion and lidocaine (Drug)

结局指标

主要结局

The level of the stress response by serum level of insulin-like growth factors

时间窗: Intraoperative and 24hours after surgery

The serum level of insulin-like growth factors will be measured at preoperative, intraoperative after one hour of intubation, at the end of surgery and after extubation, and transfer to the intensive care unit.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noha Ali Galal

Assistant lecturer of Anesthesia, ICU and pain Relief South Egypt Cancer Institute- Assiut University

Assiut University

研究点 (1)

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